Cancer DiagnosisNCT06523868
Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
A study testing GRAIL Galleri in people with Cancer Diagnosis, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Diagnosis
- What is being tested?
- GRAIL Galleri
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active-duty or National Guard/Reserves military service for four or more years
- Age ≥ 45
- Received care at a VA facility within past 5 years
- Able to sign informed consent
- Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if screening test indicates possible malignancy
Who cannot join
- Individuals diagnosed with invasive malignancy within 3 years of enrollment (non- melanoma skin cancer is acceptable)
- Individuals with evidence of symptomatic or active cancer requiring therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is acceptable)
- Individuals in the process of being evaluated for a clinical suspicion of cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Elizabeth O'Donnell, MD, 857-215-2361, elizabeth_odonnell@dfci.harvard.edu
Elizabeth ODonnell, MD
About this study
The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty.
The name of the screening blood test being studied is:
-GRAIL Galleri MCED test
Read the detailed description
This research study aims to assess the performance of the Galleri multi-cancer early detection (MCED) screening test in a military population and to compare the number and types of cancers diagnosed using MCED testing versus standard of care. This research study will give doctors and participants results of Galleri® blood tests which is designed to detect many types of cancer.
The research study procedures including screening for eligibility, blood draws, questionnaires, and clinic visits.
Participation in this research study is expected to last for up to 1 year.
It is expected that about 1,500 people will take part in this research study.
The Department of Defense (DoD) is funding this study.
- Conditions
- Cancer Diagnosis
- Being tested
- GRAIL Galleri
- Keywords
- Cancer Diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRAIL GalleriOther
A multi-cancer early detection (MCED) blood test.
| Study group | Role | What they receive |
|---|---|---|
| Galleri MCED Test | Experimental | Enrolled participants will complete:
* Baseline visit with blood draw and questionnaires
* Return of study test result
* Online post-test questionnaire
* For a positive result, diagnostic work-up could include clinic visits, biopsy, surgery, imaging assessments such as ultrasound, Computed Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. If no cancer is found upon work up, a repeat MCED test may be ordered at the discretion of the principle investigator for up to 1 year from the initial MCED blood test.
* Follow-up for a negative MCED blood test could include a repeat test ordered by the principle investigator for up to 1 year from the initial MCED test or a survey or phone call by study staff approximately 1 year after the initial MCED blood test.
* Online post-diagnostic questionnaire. Receives: Other: GRAIL Galleri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value at 12 Months
Positive predictive value is defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" on GRAIL Galleri MCED test results.
Measured: At 12 months
Negative predictive value at 12 Months
Negative predictive value is defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" on GRAIL Galleri MCED test results.
Measured: At 12 months
Specificity Rate at 12 Months
Specificity is defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis on GRAIL Galleri MCED test results.
Measured: At 12 months
Yield Rate at 12 Months
Yield rate is defined as the proportion of participants with "signal detected" out of all participants tested on GRAIL Galleri MCED test.
Measured: At 12 months
Number of Participants Needed to Screen at 12 months
Number Needed to Screen (NNS) is defined as the number of participants screened to detect a diagnosis of invasive cancer on the GRAIL Galleri MCED test.
Measured: At 12 months
Secondary outcomes (4)
Cancer Detection Rate Comparison
Descriptive statistics will be used to summarize the number and types of cancers diagnosed by GRAIL Galleri MCED testing compared to Standard of Care (SOC) in matched population from the VA (separate IRB protocol).
Measured: Up to 12 months
Stage of Invasive Cancer Diagnosis Comparison
Descriptive statistics will be used to summarize the stages of invasive cancer that are diagnosed by GRAIL Galleri MCED testing assessed by medical record review compared to Standard of Care (SOC) in matched population from the VA (separate IRB protocol).
Measured: Up to 12 months
Change in PROMIS Anxiety Short Form Score
Changes in anxiety following the GRAIL Galleri MCED test result and assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Emotional Distress Anxiety - Short Form 6a, which is a 6 item survey that is rated on a 5-point Likert scale with answers ranging from "Never" to "Always". The range of scoring is from 6 to 30 with higher scores indicating greater severity of anxiety.
Measured: Baseline to 12 months
Change in PROMIS Global Health Score
Changes in health-related quality of life following the GRAIL Galleri MCED test result and assessed by PROMIS Scale v1.2 - Global Health, a 10 item survey that is rated on a 5-point Likert scale with answers ranging from "Excellent/Completely/Never/None" to "Poor/Not at all/Always/Very Severe" and includes a pain average question rated on a scale of 0 "No Pain" to 10 "Worst Pain Imaginable." The range of scoring is from 9 to 45 with higher scores indicating higher quality of life.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start31 Mar 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Elizabeth ODonnell, Dana-Farber Cancer Institute
- Investigators
- Elizabeth ODonnell, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523868
- Sponsor's protocol ID
- 24-277
- Status last verified
- Feb 2026
- First submitted
- 23 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Military Population: The Sentinel Study
- ClinicalTrials.gov ID
- NCT06523868
- Acronym / sponsor ID
- 24-277
- Conditions
- Cancer Diagnosis
- Keywords
- Cancer Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the possible benefits of an investigational, but commercially available Galleri multi-cancer early detection (MCED) blood test which is designed to detect many types of cancer early in veterans who have served in the military in active duty.
The name of the screening blood test being studied is:
-GRAIL Galleri MCED test
Detailed description
This research study aims to assess the performance of the Galleri multi-cancer early detection (MCED) screening test in a military population and to compare the number and types of cancers diagnosed using MCED testing versus standard of care. This research study will give doctors and participants results of Galleri® blood tests which is designed to detect many types of cancer.
The research study procedures including screening for eligibility, blood draws, questionnaires, and clinic visits.
Participation in this research study is expected to last for up to 1 year.
It is expected that about 1,500 people will take part in this research study.
The Department of Defense (DoD) is funding this study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galleri MCED Test | Experimental | Other: GRAIL GalleriEnrolled participants will complete: * Baseline visit with blood draw and questionnaires * Return of study test result * Online post-test questionnaire * For a positive result, diagnostic work-up could include clinic visits, biopsy, surgery, imaging assessments such as ultrasound, Computed Tomography (CT) scans, or Magnetic Resonance Imaging (MRI) scans. If no cancer is found upon work up, a repeat MCED test may be ordered at the discretion of the principle investigator for up to 1 year from the initial MCED blood test. * Follow-up for a negative MCED blood test could include a repeat test ordered by the principle investigator for up to 1 year from the initial MCED test or a survey or phone call by study staff approximately 1 year after the initial MCED blood test. * Online post-diagnostic questionnaire. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active-duty or National Guard/Reserves military service for four or more years
- Age ≥ 45
- Received care at a VA facility within past 5 years
- Able to sign informed consent
- Willingness to travel to Dana-Farber Cancer Institute in Boston, MA, for diagnostic testing if screening test indicates possible malignancy
Key exclusion criteria (3 listed)
- Individuals diagnosed with invasive malignancy within 3 years of enrollment (non- melanoma skin cancer is acceptable)
- Individuals with evidence of symptomatic or active cancer requiring therapeutic intervention at the time of participation (hormone therapy for breast/prostate cancer is acceptable)
- Individuals in the process of being evaluated for a clinical suspicion of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRAIL GalleriA multi-cancer early detection (MCED) blood test. | Other | Galleri MCED Test |
Primary outcome
Positive predictive value at 12 Months
Time frame: At 12 months
Positive predictive value is defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" on GRAIL Galleri MCED test results.
Negative predictive value at 12 Months
Time frame: At 12 months
Negative predictive value is defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" on GRAIL Galleri MCED test results.
Specificity Rate at 12 Months
Time frame: At 12 months
Specificity is defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis on GRAIL Galleri MCED test results.
Yield Rate at 12 Months
Time frame: At 12 months
Yield rate is defined as the proportion of participants with "signal detected" out of all participants tested on GRAIL Galleri MCED test.
Number of Participants Needed to Screen at 12 months
Time frame: At 12 months
Number Needed to Screen (NNS) is defined as the number of participants screened to detect a diagnosis of invasive cancer on the GRAIL Galleri MCED test.
4 secondary outcomes
Cancer Detection Rate Comparison
Time frame: Up to 12 months
Stage of Invasive Cancer Diagnosis Comparison
Time frame: Up to 12 months
Change in PROMIS Anxiety Short Form Score
Time frame: Baseline to 12 months
Change in PROMIS Global Health Score
Time frame: Baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth ODonnell, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRAIL Galleri in people with Cancer Diagnosis, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth ODonnell, MD (857-215-2361, elizabeth_odonnell@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value at 12 Months (time frame: At 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.